New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Version 9.0 - Department of Health Public Health New Brunswick December 10, 2021
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Version 9.0 Department of Health Public Health New Brunswick December 10, 2021
Public Health New Brunswick New Brunswick Department of Health PO Box 5100 Fredericton, New Brunswick, E3B 5G8 Canada This report is available online: www.gnb.ca/publichealth Ce document est aussi disponible en français sur le titre «Guide sur la vaccination contre la COVID-19 pour les Vaccinateurs du Nouveau-Brunswick ».
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers TABLE OF CONTENTS NEW BRUNSWICK COVID-19 CLINIC GUIDE FOR IMMUNIZERS V9.....................................................1 SUMMARY OF CHANGES IN VERSION #9 ...............................................................................................1 1.0. PURPOSE .......................................................................................................................................1 2.0. VACCINE STORAGE AND HANDLING .........................................................................................1 For information on Vaccine Storage and Handling refer to the following documents: ........................................................................................................................................... 2 For guidance on storage, handling, and transportation of ultra-low temperature COVID-19 vaccines, please refer to the following documents :.................................. 2 For more information on packing and using portable freezers with COVID-19 vaccines in the frozen state (-25°C to -15°C), please refer to the following documents : .......................................................................................................................................... 2 For information on temperature excursions, please refer to: ..................................... 2 For sites storing publicly funded vaccine: .................................................................... 2 COVID Vaccines – special considerations for storage and handling ........................ 3 3.0. COVID-19 VACCINE PRODUCTS AND LABELS .........................................................................3 Carton Labelling of COVID-19 Vaccines ........................................................................ 4 4.0. REDUCING UNNECESSARY VACCINE WASTAGE ....................................................................4 Context .............................................................................................................................. 4 Planning and prioritizing individual vaccination over wastage .................................. 5 Extra doses; mixing and pooling of vials ...................................................................... 5 Reporting Wastage .......................................................................................................... 6 5.0. DEFINITIONS FOR REACHING FULL VACCINATION STATUS IN A PRIMARY VACCINE SERIES WITH HEALTH CANADA APPROVED AND NON-APPROVED COVID-19 VACCINES .........................................................................................................................................................6 Definition of a complete COVID-19 vaccine primary series to be considered fully vaccinated against SARS-COV-2: .................................................................................. 6 Definition of a complete COVID-19 vaccine series to be considered fully vaccinated in primary series AND for obtaining New-Brunswick’s “Green Pass”: ..................... 7 6.0. VACCINE INTERCHANGEABILITY ...............................................................................................7 Intercheangeability of COVID-19 vaccines in a primary series when the first dose is: ........................................................................................................................................... 7 Intercheangeability of COVID-19 vaccines with boosters ........................................... 8 7.0. NB RECOMMENDED INTERVALS FOR COVID-19 VACCINES ..................................................8 Recommended intervals in a primary series for youth and adult aged 12 and over .. ........................................................................................................................................... 8 Recommended intervals in a primary series for children aged 5-11 years old ....... 10 Recommended intervals and current eligibility for additional doses AND booster doses of COVID-19 Vaccines ........................................................................................ 10 8.0. BOOSTER VACCINE DOSAGE AND VACCINE PREFERENCES FOR CERTAIN AGE COHORTS .....................................................................................................................................12 Giving a full dose versus a half dose applies only to mRNA booster vaccines: .... 12 Preferred vaccine for 2nd and additional doses for youth and adult aged 12-29 .... 13 9.0. CONSENT FOR SUBSEQUENT VACCINE DOSES ...................................................................14 10.0. IMMUNIZATION RECORD PROCEDURE FOR SUBSEQUENT VACCINE DOSES..................14 11.0. REPORTING ADMINISTERED DOSES .......................................................................................15 12.0. VACCINE AGE ELIGIBILITY ........................................................................................................17
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Youth and Adult Pfizer aged 12 and older................................................................... 17 Pediatric Pfizer aged 5-11 years old ............................................................................ 17 13.0. VACCINE AND PAYMENT FOR SERVICES ...............................................................................17 14.0. TIMING OF COVID-19 VACCINES WITH OTHER VACCINES AND IMMUNOLOGICAL PRODUCTS ...................................................................................................................................18 Co-administration of COVID-19 Vaccines with Other non-COVID Vaccines: .......... 18 Timing of COVID-19 vaccines with monoclonal antibodies or convalescent plasma ......................................................................................................................................... 19 Timing of COVID-19 vaccines with tuberculosis skin tests (TST) and interferon gamma-release assays (IGRA) tests ............................................................................ 19 15.0. VACCINATION OF PEOPLE WITH PREVIOUS SARS-COV-2 INFECTION ..............................20 16.0. VACCINATION OF PEOPLE WITH NEEDLE PHOBIAS, FEARS OR ANXIETIES ....................20 Needle Phobia, Fears or Anxiety .................................................................................. 20 Strategies in Reducing Vaccine Pain, Fears and Anxiety ......................................... 20 Special Clinics for People with Needle Phobia, Fears or Anxiety ............................ 21 17.0. CONTRAINDICATIONS AND PRECAUTIONS ............................................................................22 Managing Contraindications and Possible Allergic Reactions................................. 22 18.0. ANAPHYLAXIS .............................................................................................................................22 Management of Anaphylaxis ........................................................................................ 22 Medical Directive for Obtaining Consent, Administering Vaccine and Managing Anaphylaxis .................................................................................................................... 23 Vaccine Allergy Risk Assessment process ................................................................ 23 19.0. MEDICAL EXEMPTIONS ..............................................................................................................23 20.0. MANAGING COVID-19 VACCINATION ADMINISTRATION ERRORS ......................................24 Vaccine Error Prevention .............................................................................................. 24 COVID-19 Vaccine Administration Errors ................................................................... 24 21.0. ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) .......................................................26 Side Effects Post COVID-19 Vaccination..................................................................... 26 Reporting Adverse Events ............................................................................................ 28 22.0. VACCINE INJURY SUPPORT PROGRAM (VISP) ......................................................................29 23.0. RESOURCES ................................................................................................................................29 APPENDIX A– AEFI PROCESS MAP .......................................................................................................31 ii
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers NEW BRUNSWICK COVID-19 CLINIC GUIDE FOR IMMUNIZERS V9 0B Summary of changes in version #9 Note: Most sections of the New Brunswick COVID-19 Clinic Guide for Immunizers version 9 have been edited and changes will not be summarized in this version 1.0. PURPOSE The purpose of this document is to provide clinical guidance about COVID-19 vaccination in New Brunswick. The primary target audience for this document are all Health and Allied Health Care Practitionners who are immunizing with COVID-19 vaccines and are referred to as “Immunizers” throughout this Guide. For information on how to plan a community immunization clinic, pop up clinic or other alternate immunization clinic sites, please refer to the New Brunswick COVID-19 Community Clinic Planning Guide which was adapted from the Public Health Agency of Canada (PHAC). This clinical guide is meant to complement and does not replace information provided in the New Brunswick Immunization guide, NACI’s Recommendation on the Use of COVID-19 vaccines or the vaccine Product Monograph. General healthcare professional COVID-19 resources can be found on the GNB Vaccines website. 2.0. VACCINE STORAGE AND HANDLING It is important that clinic sites are equipped to ensure the integrity and effectiveness of the vaccine (i.e. cold chain and other procedures). Vaccine efficacy is best assured when the number of times vaccines are handled and transported is minimized. Special attention will be required for the storage and handling of COVID-19 vaccines, as some COVID-19 vaccines may require storage at ultra-low temperatures (-80°C) or freezer temperatures (-25°C to -15°C), while others will require + 2 to 8°C storage, as per manufacturers’ specifications. 1
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers If the transportation of vaccines to another location is required, it is critical that vaccine potency is protected by maintaining cold chain at all times transport vaccines. For information on Vaccine Storage and Handling refer to the following documents: • Standard Operating Procedures on Transportation of COVID-19 Vaccines • National Vaccine Storage and Handling Guidelines for Immunization Providers – 2015 • New Brunswick Immunization Program Guide-standard 3-4-e pdf (gnb.ca) • Canadian Immunization Guide (CIG), Part 1 – Key Immunization for additional general information. For guidance on storage, handling, and transportation of ultra-low temperature COVID-19 vaccines, please refer to the following documents : • Standard Operating Procedures on Transportation of COVID-19 Vaccines • COVID-19: Interim national vaccine storage, handling and transportation guidelines for ultra-low temperature and frozen temperature COVID-19 vaccines. • Guidelines for Use: COVID-19 Vaccines and Portable Freezers For more information on packing and using portable freezers with COVID-19 vaccines in the frozen state (-25°C to -15°C), please refer to the following documents : • Pediatric Pfizer 5 to less than 12 years | CVDVACCINE. The storage and handling information differ depending on which presentation of the Pfizer vaccine is considered. Additional information on storage and handling can be found on the GNB Health Care Professional Resources section for children aged 5-11. • The Janssen Vaccine administration, storage and handling guide as well as the GNB Health Care Professional Resources For information on temperature excursions, please refer to: • The product monographs on GNB’s Website: Vaccine Resources for Healthcare Professionals and contact the manufacturer for specific recommendations • Heat or cold exposure can cause damage to COVID-19 vaccines in storage. It is important that, when they occur, the appropriate actions take place to preserve the integrity of the vaccines. When temperature excursions occur, the user at the vaccine delivery site should follow the actions outlined: National Vaccine Storage and Handling Guidelines for Immunization Providers – 2015. For sites storing publicly funded vaccine: • The site should have an operational plan in place in the event of a power failure. Refer to NBIPG-appendice5-4.pdf (gnb.ca) Guidance for Vaccine Response Plan in the event of power failure Some facilities will be required to use specific temperature-monitoring devices such as Digital data loggers, as not all facilities are equipped with backup power and alarm systems. Data loggers are continuous monitoring and recording devices that provide detailed information on all temperatures recorded at pre-set intervals. Data loggers can indicate when an adverse temperature exposure occurs and how long the vaccines were exposed to the min/max temperature for. For ConsolePlus Dataloggers, please see the Quick Start Guide 2 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers and instructions on how to use them. A Vaccine Command Centre (VOC) has been created to address vaccine concerns, i.e. shipment issue, power outages, vaccine excursions, etc. To contact the Vaccine Operation Control Center: Email: VOC-opsDesk@GNB.CA Telephone: 833-414-2369 COVID Vaccines – special considerations for storage and handling Vaccines may have specified time frames when they can be kept at room temperature, used once mixed with diluent or adjuvant, used once the vial is punctured and/or when pre-loaded into a syringe. The start time and end time for these time frames should be written down and the paper stuck to or kept close to the product so that the time frames can be closely monitored. Mixed vaccine vials and pre-loaded syringes that are not being used immediately may need to be stored in an insulated bag or cooler or may be able to be stored at room temperature, based on the manufacturer’s recommendations. If stored in an insulated bag or cooler, these should have frozen packs and an appropriate insulating barrier (e.g., bubble wrap, crumpled paper, Styrofoam peanuts) which is positioned so that the vaccine vial or pre-loaded syringes do not touch the frozen packs to prevent freezing the vaccine. If the vaccine remains in the insulated bag for more than an hour, temperature should be monitored and recorded. Vaccines stored at ultra-low temperatures (-80°C) or in a freezer (-20°C) will need to be thawed before use and cannot be refrozen. Manufacturer’s instructions should be followed regarding the thawing process in the refrigerator and/or at room temperature. Each vaccine has a limited number of days when they can be maintained at +2°C to 8°C before administration. Therefore, a sufficient supply to accommodate the anticipated needs of the clinic should be thawed and available at the clinic. The date the product was thawed and the date which it should be used by should be clearly marked on the thawed vial and/or outer package. Some vaccines may be required to be at room temperature before administering. There are exceptional circumstances when clients are unable to attend clinic sites, where immunizers may require transporting and administering COVID-19 vaccines in prefilled syringes. For more information, please refer to the Department of Health’s Exceptional Circumstances Policy: Prefilling syringes for onward transportation COVID-19 vaccine doses. 3.0. COVID-19 VACCINE PRODUCTS AND LABELS COVID-19 vaccine product information is highly subject to change. For detailed, up-to-date information on COVID-19 vaccines including approved vaccines, types of vaccines and on-going safety monitoring please refer to Health Canada’s page on authorized COVID-19 Vaccines. You can also search Health Canada’s Drug Product Database by Drug Identification number or under criteria, select “Schedule” COVID-19 - IO - Authorization. 3
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Regulatory information on all authorized COVID-19 vaccines can be found on the COVID-19 vaccines and treatments portal website. Other vaccine product information can also be found on the New-Brunswick Vaccine resources for health professionals (gnb.ca) website, or on the product monograph within each carton. Carton Labelling of COVID-19 Vaccines In order to expedite the distribution of the vaccine in Canada, at times immunizers may be advised of a US or EU labelled vaccine supply with interim English-only vial and carton labels in order to expedite the distribution of the vaccine in Canada. Important Canadian-specific information may be absent from the labelled vial and carton. The Canadian Product Monograph, which is available in French and English on Health Canada’s Drug Product Database, the federal government’s COVID-19 vaccines and treatments portal website, should continue to be be referenced for complete product information. Information will also be communicated to the immunization coordinators by email in a timely manner as well as added to the webpage: Vaccine resources for health professionals (gnb.ca) 4.0. REDUCING UNNECESSARY VACCINE WASTAGE Direction to reduce unnecessary vaccine wastage given at clinics and pharmacies is based on New-Brunswick’s Vaccine Strategy Planning Principles and the provincial approach to reducing minimize open-vial COVID-19 vaccine wastage. Context As we approach our targeted vaccination goal, decreasing demand from the public, a readily available vaccine supply and continued limitations related to storage and transportation of COVID mRNA vaccines, it is acknowledged that vaccine wastage may increase. Canada is now in a surplus position with regard to COVID-19 vaccine supply, but globally many countries have very limited access to COVID-19 vaccines and therefore it is very important to further maximize the use of the vaccines and limit avoidable wastage. Vaccine wastage can be expected in all immunization programs. Closed vial wastage (wastage in unopened vials) is usually attributable to cold chain management problems and can be minimized. Open vial wastage (wastage in opened vials) cannot be eliminated, but can be reduced by using New-Brunswick’s Vaccine Strategy Planning Principles and practices. • Secure Transportation: To ensure that vaccine wastage is minimized, it is critical that vaccine potency is protected by maintaining cold chain at all times during transportation. Manufacturer guidelines should be followed. Refer to the SOP Transportation of COVID Vaccines and the Exceptional Circumstances Policy: Pre- filling syringes for onward transportation COVID-19 vaccine doses. • Integrity: The main supply of vaccine should be housed at a facility with a Drug Establishment License (DEL), i.e. with McKesson. It is recommended that all 4 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers immunizers, clinic and pharmacies continue to have contingency plans in place for any vaccine inventory. • Communication: As we move forward, local and regional regular communication and cooperation between all immunizers, clinics and pharmacies is highly encouraged. This will help make the conclusion of this COVID-19 vaccine campaign more efficient and successful. It is best to have plans for storage and transportation in advance for additional vaccine recipients in the event of no shows or extra doses, with a final option to provide to those available in the area at the time. Achieving very high coverage is important for the following reasons: • To directly protect as many people as possible from SARS-CoV-2 infection, COVID-19 disease, and severe COVID-19 outcomes; • To help prevent spread of infection to others, as well as to help prevent the start and spread of outbreaks; • To decrease circulation of the virus in the community contributing to a herd effect. Every one that is immunized against COVID contributes to the overall protection of the population. Planning and prioritizing individual vaccination over wastage Given that only multi-dose vials are available in Canada, some wastage is inevitable as efforts are made to immunize remaining unvaccinated or partially vaccinated people, particularly when vaccines are offered outside of larger immunization clinics (e.g. when vaccines are offered in pharmacies, health care providers’ offices, and remote and isolated communities). There may be circumstances where a new vial must be opened to vaccinate only one or a few people, and plans cannot be implemented to use the remaining doses in the vial. Having plans to immunize as many people as possible when a vial is opened/reconstituted continues to be important for planning, however more importantly is ensuring that vaccine doses are readily available. • Ensure access to COVID-19 vaccine at clinic sites. • Utilize social media to advertise extra available COVID-19 vaccines. • For those that do not want to interchange their vaccines, having both vaccine products available as much as possible at clinics will ensure that individuals have choice and can complete their series with the same vaccine. • Providing options is permissible when there is vaccine surplus to ensure that hesitancy and vaccine opportunities are maximized and takes priority over vaccine wastage. • Providers should not miss any opportunities to vaccinate every eligible person who presents for vaccination, even if it means puncturing a multi-dose vial and needing to discard the remainder of the vial. Extra doses; mixing and pooling of vials A plan, such as a wait list or transportation of thawed closed vials or pre-filled syringes, should be made for any extra vaccine that may be available at end of clinic. 5
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Early shortfall and delays in COVID-19 vaccine supply precipitated the option of pooling vaccine across two or more vials to maximize the number of doses available. As of November 2021 and anticipation of abundant supply, Public Health New Brunswick is no longer supporting the practice of dose pooling. Reporting Wastage The federal government requires that the province reports all vaccine wastage on a weekly basis. All those who have been allocated vaccine doses are required to share vaccine wastage information with Public Health to fulfill this federal requirement. For RHA, LTC and First Nations clinics, all wasted doses should be captured in the Clinic Tracking worksheets in the COVID Immunization SharePoint site. COVID-19 vaccine wastage is reported by full doses (ie: Moderna ½ booster doses wasted are reported as 1 full dose wasted). For community pharmacies, the Vaccine Wastage Report located on the Drug Information System’s Community Pharmacy SharePoint site must be completed when wastage occurs. If reporting wastage for more than one brand of COVID-19 Vaccine (e.g. Moderna and Pfizer), or reporting wastage for different Lot numbers, multiple entries are required. 5.0. DEFINITIONS FOR REACHING FULL VACCINATION STATUS IN A PRIMARY VACCINE SERIES WITH HEALTH CANADA APPROVED AND NON-APPROVED COVID-19 VACCINES COVID-19 vaccines authorized for use by Health Canada : • AstraZeneca Vaxzevria (Covishield) – viral vector vaccine • Janssen (Johnson & Johnson) – viral vector vaccine • Moderna Spikevax – mRNA vaccine • Pfizer-BioNTech Comirnaty – mRNA vaccine It is very important to distinguish between an additional dose in the primary series for immunocompromised individuals and booster doses for the general population (see ection 5.1). The term “subsequent dose” is used in this document as well to describe either additional or booster dose as the “next” recommended dose. Definition of a complete COVID-19 vaccine primary series to be considered fully vaccinated against SARS-COV-2: A primary vaccine series is considered to be the number of initial doses of vaccine given to induce an immune response and provide initial protection. The primary series defitnion for the general population differs than for those who are identified as being moderately or severely immunocompromised. For the general population, a complete COVID-19 primary vaccine series definition is 14 days after receiving: • Two doses of the Pfizer-BioNTech, Moderna or AstraZeneca/COVISHIELD vaccines (or any combination thereof) or one dose of the Janssen vaccine. For the identified moderately to severely immunocompromised population aged 12 and over, a completed COVID-19 primary vaccine series definition is 14 days after receiving: 6 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers • Two doses of the Pfizer-BioNTech, Moderna or AstraZeneca/COVISHIELD vaccines (or any combination thereof) or one dose of the Janssen vaccine AND: o An additional dose of an authorized mRNA vaccine if they have previously received a 1- or 2-dose primary series, including people who received a mixed vaccine schedule. This means a total of 3 doses is recommended (or 2 doses if individuals received Janssen as a primary series). Definition of a complete COVID-19 vaccine series to be considered fully vaccinated in primary series AND for obtaining New-Brunswick’s “Green Pass”: In New Brunswick, you're considered fully vaccinated and able to obtain your “Green Pass” status 14 days after you have any of the following COVID-19 vaccine combinations: • 2 full doses of AstraZeneca or COVISHIELD • 2 full doses of Moderna • 2 full doses of Pfizer • 2 full doses of a combination of either of the following COVID-19 vaccines: AstraZeneca, COVISHIELD, Moderna and Pfizer • 1 full dose of Janssen (Johnson & Johnson) A traveler who has received one or two doses of a non-Health Canada approved/authorized vaccine, must receive one additional mRNA vaccine to be considered fully vaccinated in New Brunswick and receive a green pass for entry into businesses. The minimal interval between the preceding dose and the additional dose must be 28 days. No additional doses should be offered to any individuals in the general population who already received three doses of any COVID-19 vaccine. 6.0. VACCINE INTERCHANGEABILITY The Public Health Agency of Canada released a Summary of the Rapid Response, on June 1st, 2021, with updated recommendations from the National Advisory Committee on Immunization (NACI) on the interchangeability of authorized COVID-19 vaccines (also referred to as ‘mixed vaccine schedules’). These recommendations are based on current scientific evidence and NACI’s expert opinion. Intercheangeability of COVID-19 vaccines in a primary series when the first dose is: An mRNA COVID-19 vaccine: NACI recommends that : if readily available*, the same mRNA COVID-19 vaccine product should be offered for the subsequent doses in a vaccine series started with an mRNA COVID-19 vaccine. However, when the same mRNA COVID-19 vaccine product is not readily available*, or is unknown, another mRNA COVID-19 vaccine product recommended for use in that age group can be considered interchangeable and should be offered to complete the vaccine series. The previous dose should be counted, and the series need not be restarted *readily available = easily available at the time of vaccination without delay or vaccine 7
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers wastage Note: for immunocompromised individuals, a primary series is now 3 doses. An AstraZeneca/COVISHIELD COVID-19 vaccine: For those who received AstraZeneca/COVISHIELD COVID-19 vaccine as a first dose regardless if they are under 55 years or 55 years and older, NACI recommends that: an mRNA COVID-19 vaccine should be offered for the second dose. Only offer an AstraZeneca/COVISHIELD COVID-19 vaccine if an individual refuse a mRNA vaccine or if a mRNA vaccine is contraindicated. Informed consent should include discussion about the risk and benefits of the vaccine, symptoms of VITT, as well as the need to seek immediate medical care should symptoms develop. A Janssen Vaccine: Only offer a Janssen vaccine if an individual refuses a mRNA vaccine or if a mRNA vaccine is contraindicated. The Janssen is given as a one-dose vaccine and the primary series is considered completed. Intercheangeability of COVID-19 vaccines with boosters Regardless of any vaccine received in a primary series (section 6.1) all additional and booster doses are always offerered with an mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna) and are considered interchangeable as per the National Advisory Committee on Immunization (NACI) on the interchangeability of authorized COVID-19 vaccines. A booster dose of an authorized viral vector vaccine should only be considered when other authorized COVID-19 vaccines are contraindicated or inaccessible. Informed consent should include discussion about the risk and benefits of an mRNA COVID-19 product is preferred as a booster. If giving a viral vector as a booster, regardless of any vaccine received in a primary series (section 5.1 and 6.1) it is interchangeable. Note: for immunocompromised individuals, a primary series is now considered 3 doses. The booster dose for this population is considered a “4th” dose. 7.0. NB RECOMMENDED INTERVALS FOR COVID-19 VACCINES Recommended intervals in a primary series for youth and adult aged 12 and over On October 22, 2021, NACI released new updated guidance on the optimal interval between the first and second doses of a two-dose COVID-19 primary vaccine series. Following this guidance, New Brunswick now recommends that individuals get their second dose of vaccine eight weeks after receiving their first dose to ensure optimal protection however individuals are still able to receive their 2nd dose at 28 days. 8 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Note: All primary series vaccines are given at their full doses: • A Pfizer-BioNTech dose: 30mcg: 0.3 ml • A Moderna dose: 100mcg: 0.5 ml • An Astra Zeneca dose: 0.5 ml • A Janssen dose: 0.5 ml TABLE 1.0 INTERVALS BETWEEN DOSE 1 AND DOSE 2 IN A PRIMARY SERIES FOR YOUTH AND ADULT AGED 12 AND OVER Dose 1 Dose 2 NB’s recommended optimal interval between dose 1 and dose 2, as of October 2021 8 weeks (28 days Pfizer Pfizer accepted) Moderna Moderna 8 weeks (28 days accepted 8 weeks (28 days Pfizer Moderna accepted) 8 weeks (28 days Moderna Pfizer accepted) AstraZeneca/ 8 weeks (28 days Moderna COVISHIELD accepted) AstraZeneca/ 8 weeks (28 days Pfizer COVISHIELD accepted) AstraZeneca/ AstraZeneca/ 8 Weeks (28 days COVISHIELD COVISHIELD accepted) Janssen* N/A N/A For immunocompromised** individuals, a primary series is now considered 3 doses. NB’s recommended optimal interval between dose 2 and dose 3 (or dose 1 and 2 for Janssen) as of December 2021: Immunocompromised having received any of the following 28 days vaccines: Pfizer, Moderna or Astrazeneca: Immunocompromised having 28 days received a Janssen vaccine for dose 1 Note: • *Janssen vaccine is given as one dose and is considered a completed primary series in the general population. For booster doses, please see the Table 3.0 • **For immunocompromised individuals, a primary series is now considered 3 doses. A booster dose in this population is now considered dose 4. See section 5.1 • For interval deviations or maximum accepted vaccine intervals, refer to the section of the guide on MANAGING COVID-19 VACCINATION ADMINISTRATION ERRORS 9
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Recommended intervals in a primary series for children aged 5-11 years old On November 19th, NACI released the recommendation on the use of the Pfizer-BioNTech COVID-19 vaccine (10 mcg) in children 5 to 11 years of age. New-Brunswick is following NACI’s guidance on the optimal interval between the first and second doses of a two-dose COVID-19 primary vaccine series for children aged 5-11. To ensure optimal protection, The second dose is given at least eight weeks after receiving their first dose. TABLE 2.0 - INTERVALS BETWEEN DOSE 1 AND DOSE 2 IN A PRIMARY SERIES FOR CHILDREN AGED 5 -11 YEARS OLD NB’s recommended Dose 1 Dose 2 optimal interval between dose 1 and dose 2 Pfizer Pediatric dose Pfizer Pediatric dose 8 weeks Pfizer Pediatric dose Pfizer Adult dose* 8 weeks Note: • *See section 12.2 of this guide for: Children who receive the Pfizer Pediatric dose (10 mcg) vaccine for their first dose and who have turned 12 years of age by the time the second dose is due • For interval deviations , refer to the section of the guide on MANAGING COVID-19 VACCINATION ADMINISTRATION ERRORS Recommended intervals and current eligibility for additional doses AND booster doses of COVID-19 Vaccines On December 3rd, 2021, NACI released a new interim guidance on booster COVID-19 vaccine doses. It is very important to distinguish between an additional dose in the primary series for immunocompromised individuals and booster doses for the general population (see section 5.1). 1. The following group can now book an appointment for their ADDITIONAL primary series dose of an mRNA COVID-19 vaccine in New-Brunswick if at least 28 days have passed since their SECOND dose: • Individuals 12 and over who are moderately to severely immunocompromised due to a medical condition or treatment. A complete list of complex medical conditions and treatments can be found on the Declaration of Eligibility form. Individuals will need to sign this form attesting that they meet the eligibility criteria. 2. The following groups in the general population can now book an appointment for their BOOSTER dose of an mRNA COVID-19 vaccine in New-Brunswick if at least 28 days have passed since their SECOND dose: • Fully immunized individuals who have received one or two doses of the AstraZeneca Vaxzevria/COVISHIELD vaccine in their series, regardless of their age. 10 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers • Individuals who received a mixed vaccine series and must travel outside of North America for work, education or medical procedures. These individuals must provide a letter that includes their first and last name that shows their travel outside North America is essential. • Individuals who received one dose of the Janssen vaccine 3. The following groups can now book an appointment for their BOOSTER dose of an mRNA COVID-19 vaccine in New-Brunswick if at least 5 months has passed since their SECOND dose: • All Residents of long-term care facilities. Note: Most of these individuals will also fall under the immunocompromised group. If they meet the requirements of being a moderately to severely immunocompromised individual, follow the recommendations of needing 3 doses in a primary series plus a booster. The booster dose (ie 4th dose) should be given at least 6 months since their THIRD dose and in accordance to the current NB booster eligibility age criteria. 4. The following groups in the general populations can now book an appointment for their BOOSTER dose of an mRNA COVID-19 vaccine in New-Brunswick if at least six months has passed since their SECOND dose: • All First Nation individuals • All Health-care personnel – including those working in long-term care facilities • All Individuals 50 and older • All School personnel TABLE 3.0 - INTERVAL BETWEEN DOSE 2 AND SUBSEQUENT DOSES FOR ELEGIBLE POPULATIONS Populations NB’s recommended Minimal Interval between dose 2 and subsequent doses as of December 2021 Long-term care residents 5 months Individuals 50 and older * NEW 6 months December 8th , 2021 Congregate living settings 6 months First Nation Individuals 6 months School personnel 6 months 11
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Health-care personnel – including 6 months those working in long-term care facilities 12 and over who are moderately to 28 days between dose 2 and the severely immunocompromised ADDITIONAL dose 3 for completion of primary series 50 and over who are moderately to 6 months between dose 3 and their severely immunocompromised BOOSTER dose 4* Individuals who have received one or 28 days two doses of the AstraZeneca Vaxzevria/COVISHIELD Individuals entering NB with 1 or 2 28 days doses of a non-Health Canada authorized vaccine (i.e. other than Pfizer, Moderna, Janssen or Astrazeneca) completed Individuals who must travel outside of 28 days North America for work, education or medical procedures Individuals who received one dose of 28 days the Janssen vaccine Note: • For interval deviations or maximum accepted vaccine intervals, refer to the section of the guide on MANAGING COVID-19 VACCINATION ADMINISTRATION ERRORS • *Moderate to severely immunocompromised individuals now require 3 doses in a primary series. The booster dose is dose #4. Please see the eligibility age criteria for booster doses for this population at this time 8.0. BOOSTER VACCINE DOSAGE AND VACCINE PREFERENCES FOR CERTAIN AGE COHORTS This section is for guidance on booster dosages and does not change the full dose required in the primary COVID-19 vaccine series. Giving a full dose versus a half dose applies only to mRNA booster vaccines: Pfizer: If offering a Pfizer-BioNTech Cominarty as an additional or booster dose: It is given as a FULL dose (30 mcg : 0.3 ml) and no changes at any age. Moderna: If offering a Moderna Spikevax as an additional or booster dose: 1. A full dose is given (100 mcg: 0.5ml ) and recommended for 12 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers o adults living in long-term care homes for seniors or other congregate living settings that provide care for seniors o Adults 70 years of age or older, if offering Moderna Spikevax, o Individuals who are immunocompromised (as per eligibility criteria) 2. A half dose is given (50 mcg: 0.25ml) and recommended for o those less than 70 years of age. For all clients who are eligible and receive the half dose of Moderna, the PHN will need to change the dose manually in PHIS from 0.5mL to 0.25mL when entering the vaccine. Note: Moderna has sufficient data to support that their product remains sterile and stable following 20 punctures. We do not recommend more than 20 withdrawals per vial. Preferred vaccine for 2nd and additional doses for youth and adult aged 12-29 On December 3rd, 2021, NACI released its newest recommendations for the indoviduasl in the age cohort 12-29. New Canadian and international data suggest the risk of myocarditis following vaccination with a COVID-19 mRNA vaccine is lower with the Pfizer-BioNTech Comirnaty vaccine (30 mcg) compared to the Moderna Spikevax vaccine (100 mcg), particularly after a second dose in males 12 to 29 years of age. The benefits of receiving an mRNA COVID-19 vaccine primary series continue to outweigh any potential risks of rare adverse events, including the rare risk of myocarditis in adolescents and young adults 12 to 29 years of age. However, in order to further minimize the rare risk of adolescents and young adults experiencing myocarditis and/or pericarditis after receiving a COVID-19 mRNA vaccine, NACI recommends the use of the Pfizer-BioNTech Comirnaty (30 mcg) vaccine in this age group. Public Health New Brunswick is following NACI’s recommendations. For youth and adults aged 12-29, the preferred use of the Pfizer-BioNTech Comirnaty (30 mcg) vaccine is recomended in this age group. Everyone, regardless of age, who is offered an mRNA COVID-19 vaccine should be informed of the rare risk of myocarditis or pericarditis and should be advised to seek immediate medical attention if they develop symptoms. Symptoms of myocarditis/pericarditis usually take place within a week of vaccination. Symptoms include chest pain, shortness of breath, or the feeling of a fast, pounding or fluttering heartbeat. 13
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers TABLE 4.0 - VACCINE TYPES AND PREFERRED DOSES OFFERED FOR COVID-19 VACCINE BOOSTER DOSES FOR CERTAIN POPULATIONS Population Vaccine type (and dose) which may be preferred for those currently eligible for BOOSTERS in New Brunswick as of Dec 8th , 2021: 50-69 year olds Either Moderna Spikevax (50mcg) or Pfizer Comirnaty (30mcg) may be considered. • ≥70 year olds Either Moderna Spikevax (100mcg) or Pfizer • Adults living in long-term care or Comirnaty (30mcg) may be considered. other senior congregate living settings If Moderna Spikevax vaccine is being used as the • Moderately to severely booster product, give a 100 mcg dose. immunocompromised adults* (after the recommended 3-dose primary series) Note: • Evidence following the Moderna Spikevax (50 mcg) booster dose is limited. • Moderately or severely immunocompromised adults receiving a booster dose after a primary series of three doses, will receive a total of four doses. 9.0. CONSENT FOR SUBSEQUENT VACCINE DOSES Clinic leadership will need to be established to provide overall management, planning and organization of clinic operations for successful second dose clinics. When vaccine recipients return for their second dose, it is important that the informed consent process is in place. This includes reviewing vaccine information with any updated information and providing time for clients’ questions. It should also include a review of the consent form. Sections 2 and 3 of the consent forms consists of a pre-vaccine assessment which is to be conducted at each immunization dose encounter. Since most COVID-19 vaccines require a second dose, with some individuals requiring a third dose or a booster dose, it is important to make it as easy as possible for the client to receive the subsequent dose. 10.0. IMMUNIZATION RECORD PROCEDURE FOR SUBSEQUENT VACCINE DOSES All clients should present to the immunizer an immunization record that includes the date and the vaccine they received. For RHA’s: • Review the client’s documentation of their previous dose. If the client has an immunization sheet, review it. The interval between doses should be reviewed to ensure the appropriate time has lapsed; the vaccine type should also be reviewed. Please see guidance in section 2.9 on Vaccine Interchangeability. If the client has no immunization record and there 14 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers is no evidence of a first dose administration documented in PHIS, then the client should be considered un-immunized and a first dose offered. • Review vaccine information. Review the pre-information vaccine sheet thoroughly with the client. For best practice and informed consent, ensure the client is aware of the most up to date information and is allowed time to ask questions. • Obtain a new consent for additional subsequent doses. This will ensure the pre-vaccine assessment is complete. The client and the immunizer are to sign the new consent form. After consent is obtained, document the subsequent dose and provide the immunization record (either a new record or a previous record with a documented dose) to the client. For Pharmacies: • Review the client’s documentation of previous dose. If the client has a paper immunization sheet or electronic MyHealth NB record, please review it. The interval between doses should be reviewed to ensure the appropriate time period, as set out in this guide, has lapsed; the vaccine type should also be reviewed. If the client has no immunization record, ask where the most recent dose was given. If the client’s most recent dose was given at another pharmacy, a record of that administration should be available in DIS. If there is no evidence of previous doses available in DIS or a myHealthNB record, revaccination is likely the best message in the interest of time and efficiency. • Review vaccine information. Review the pre-information vaccine sheet thoroughly with the client. For best practice and informed consent, ensure the client is aware of the most up to date information and is allowed time to ask questions. • Obtain a new consent for the subsequent dose. This will ensure the pre-vaccine assessment is complete. The client and the immunizer are to sign consent form for subsequent doses. After consent is obtained, document the subsequent dose and provide the immunization record (either a new record or a previous record with the documented previous doses) to the client. 11.0. REPORTING ADMINISTERED DOSES All administered doses must be recorded in the Public Health Information System (PHIS) in accordance with process provided to them. RHA Led Clinics: Immunizers in RHA led clinics are to enter the information directly into the Public Health Information Solution (PHIS) or to send to the PHIS Data entry team to enter. The information entered into PHIS includes the agent administered, the date of administration, the lot number and expiry date with all other relevant information. Please remember these key points when adding a COVID-19 immunization in PHIS: • Perform a thorough search when attempting to locate a client in PHIS. When the contents on the consent form do not match the PHIS search result, send the consent form to COVIDDataEntry@gnb.ca for further investigation. • When searching by Medicare number and a different client name is displayed in the search results, DO NOT overwrite that name. Create a new client record OR send the consent form to COVIDDataEntry@gnb.ca 15
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers • When entering an immunization record and a similar record already exists that you are not sure is correct, send the consent form to COVIDDataEntry@gnb.ca. The COVID Data Entry team is dedicated to assist with entering COVID-19 immunizations into PHIS. The main goal is to have the most accurate and up-to-date data in the system. Please refer to COVID Data Entry FAQs v0.5. Community Pharmacy Clinics: Immunizations in community pharmacy clinics will be captured using the drug dispense message transmitted to the DIS from the local pharmacy information system (PIS). DIS does not capture lot number and expiry date and therefore, is not captured in PHIS. Staff investigating AEFIs have been trained to start with the PHIS record and to reach out to the administering pharmacy to capture additional details including lot number and route of administration as part of any investigation. In exceptional circumstances, if the date of entry is later than actual day of administration, the drug dispense date must be adjusted. This may require “back dating” the dispense date in the pharmacy information system. New Brunswick residents without a Health Card Number (HCN) such as NB Medicare, other HCN issued out of province, or a federally administered identifier (Veterans Affairs, RCMP, National Insured Health Benefits, etc.) are eligible to receive a COVID-19 vaccine. Clients may be added to the local pharmacy system and synchronized to the NB Client Registry/DIS, leaving the HCN field blank but providing the minimum data set (first name/last name, date of birth, current address with postal code, and phone number). EXCEPTION – Jean Coutu Pharmacy locations must enter the word MISSING or ABSENT to indicate no HCN and provide the minimum data set. Pharmacies are required to identify the following groups within their Pharmacy management system for provincial reporting purposes: Rotational Workers, NB Truckers, Frequent Border Crossers and Pregnant persons. To identify receipt of vaccine for rotational workers, NB Truckers and Frequent Border Crossers, please enter the appropriate code into the SIG field of your pharmacy management system. This will send the information to DIS during prescription entry for the vaccine. For the process to identify pregnant persons, please follow the direction provided by your pharmacy information system vendor. Physician clinics: As part of participation in delivery of this COVID-19 vaccination program, Physicians and Nurse Practitioners will be required to submit COVID-19 vaccine administration billing information to Medicare as soon as possible following administration and no later than one week of the client’s receipt of vaccine. This data is necessary to accurately inform the Minister and New Brunswick population of the progress of the iCOVID-19 campaign in a timely manner and to quickly identify the batch and lot number of a vaccine associated with an adverse event, should one occur, and be able to rapidly notify providers and patients who may be affected. TABLE 5.0 - GROUPS AND CODES FOR SIG FIELD Group Code for SIG Field NB Trucker CVTR Frequent Border Crosser CVBC Rotational Worker CVRW 16 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers 12.0. VACCINE AGE ELIGIBILITY Four vaccines are currently authorized for use in Canada and in NB for these populations: • Pfizer-BioNTech (Comirnaty) – 12 years and up • Moderna (Spikevax) – 12 years and up • AstraZeneca (Vaxzevria or Covishield) – 55 years and up • Janssen – 18 years and up Youth and Adult Pfizer aged 12 and older Currently until December 31st, 2021: o Provide 2 adult doses (2 x 30mcg: 0.3ml) o *For 11-year olds that are turning 12 in 2021 (ie born in 2009), provide 2 adult doses (2 x 30mcg: 0.3ml) January 1st, 2022 onward: o Must be 12 years of age at the time of vaccination to receive adult dose (ie born in 2010 or earlier) o Provide 2 adult doses (2 x 30mcg: 0.3ml) Pediatric Pfizer aged 5-11 years old Currently until December 31st, 2021: o Children born between 2010 and 2016 are eligible to receive the COVID-19 pediatric vaccine. This includes children four years of age that are turning 5 by December 31st, 2021. o *Provide two pediatric doses (2 x 10mcg: 0.2 ml) January 1st, 2022 onward: o Children must be 5 years old at the time of vaccination *Children who receive the 10 mcg Pfizer-BioNTech COVID-19 vaccine for their first dose and who have turned 12 years of age by the time the second dose is due may receive the 30 mcg Pfizer-BioNTech COVID-19 vaccine that is authorized for individuals aged 12 years and older to complete their primary series. If the second dose of 10 mcg is given, the dose should still be considered valid and the series complete. 13.0. VACCINE AND PAYMENT FOR SERVICES COVID-19 vaccination is a publicly funded program. Any individual living in N.B. during the pandemic is eligible to receive the COVID-19 vaccine for free. This includes Canadian citizens, permanent residents, temporary visitors or international students. Proof of residency, a minimum stay in the province, or a N.B. Medicare card is not required. Community Pharmacy Clinics: Claims for payment are to be submitted as required under the New Brunswick Prescription Drug Program (NBPDP) Plan “I”. For individuals from out-of-province temporarily residing in New 17
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers Brunswick and who have not been issued a NB Medicare number, enter “999 999 999” in place of the Medicare number. Physicians: Claims for payment are to be submitted to Medicare as soon as possible following administration and no later than one week of the client’s receipt of vaccine..Refer to the Physicians Manual for billing practices. 14.0. TIMING OF COVID-19 VACCINES WITH OTHER VACCINES AND IMMUNOLOGICAL PRODUCTS Co-administration of COVID-19 Vaccines with Other non-COVID Vaccines: Public Health New Brunswick is following NACI’s recommendations. For youth and adult aged 12 and over: NACI now recommends that COVID-19 vaccines may be given at the same time as, or any time before or after, other vaccines, including live, non-live, adjuvanted, and non- adjuvanted vaccines. For children aged 5-11 year old : NACI recommends: COVID-19 vaccines for children 5-11 years old should not routinely be given concomitantly (i.e., same day) with other vaccines (live or non-live). This includes the Influenza vaccine. In the absence of evidence, it would be prudent to wait for a period of at least 14 days BEFORE or AFTER the administration of another vaccine before administrating a COVID-19 vaccine to prevent erroneous attribution of an AEFI to one particular vaccine or the other. This suggested minimum waiting period between vaccines is precautionary at this time and be revisited in the future. A similar approach was taken when the COVID vaccine was first introduced for the adult population Best practice is to follow NACI’s recommendations. If a child arrives at a clinic with having a non-covid-19 vaccine within the last 14 days, it is not necessary to turn someone away at the clinic. However, it is important that the informed consent process below is in place for parents and legal guardian to be fully aware this is not the current recommendation: • Informed consent: As per routine immunization practice all immunizers should continue to provide an informed consent process. For COVID, like any other vaccine, immunization practice should include an informed consent discussion about the vaccine specific data that is currently available, as well as the benefits and potential risks of administering a COVID-19 and non-COVID-19 vaccine at the same time. Studies looking at the simultaneous administration of COVID-19 vaccines with other vaccines, and to assess the safety and immunogenicity of concomitant administration of COVID-19 vaccines with other vaccines are ongoing. • Reactogenicity: It is currently not known if the reactogenicity of COVID-19 vaccines is increased with concomitant administration of other vaccines. While no 18 December 10, 2021
New Brunswick COVID-19 Vaccine Clinic Guide for Immunizers specific safety concerns have been identified for various other vaccines with concomitant administration regimens, there is potential for increased reactogenicity with concomitant administration of COVID-19 vaccines with other vaccines, particularly those known to be more reactogenic, such as newer adjuvanted vaccines. • Co-administrations: If more than one type of vaccine is administered at a single visit, they should be administered at different injection sites using separate injection equipment. As more information evolves NACI will continue to monitor the evidence and update recommendations as needed. For further information please refer to: • Memo on Co-administration of COVID-19 and other vaccines, circulated October 5, 2021 • NACI’s September 28, 2021: Recommendations on the use of COVID-19 vaccines • Timing of Vaccine Administration in the CIG, Part 1 – Key Immunization Information for additional general information on simultaneous administration of other vaccines Timing of COVID-19 vaccines with monoclonal antibodies or convalescent plasma For all individuals aged 5 and over: NACI recommends that COVID-19 vaccines not be given simultaneously with monoclonal antibodies or convalescent plasma. The optimal interval to wait between these products and COVID-19 vaccination is not known. For More information, see NACI’s September 28, 2021: Recommendations on the use of COVID-19 vaccines Timing of COVID-19 vaccines with tuberculosis skin tests (TST) and interferon gamma-release assays (IGRA) tests For all individuals aged 5 and over: If tuberculin skin testing or an IGRA test is required, it should be administered and read before COVID-19 vaccination or delayed for at least 4 weeks after COVID-19 vaccination. If an opportunity to perform the TST or IGRA test may be missed, testing should not be delayed. However, it may be prudent to re-test (at least 4 weeks post-vaccination) persons with negative results who are suspected of having tuberculosis. Re-testing will help to avoid missing cases due to potentially false-negative results. Vaccination with COVID-19 vaccines may take place at any time after all steps of tuberculin skin testing have been completed. For More information, see NACI’s September 28, 2021: Recommendations on the use of COVID-19 vaccines 19
You can also read